FDA Adverse Event
Malfunction
Summary report: N
OVATIO
MDR report key: 2536876
·
Received April 10, 2012
Report
- Report Number
- 9610579-2012-00039
- Event Type
- Malfunction
- Date Received
- April 10, 2012
- Date of Event
- March 20, 2012
- Report Date
- March 21, 2012
- Manufacturer
- SORIN CRM
- Product Code
- MRM
- PMA / PMN Number
- P980049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
REPORTEDLY, PT CAME TO HOSP ON (B)(6) 2012, AFTER HE RECEIVED A SHOCK WHILE HE WS CYCLING ON A STONY ROAD. FOLLOW-UP DATA STORED IN DEVICE MEMORY SHOWED THE SHOCK WAS RESULTING FROM NOISE OVERSENSING. NOISE OVERSENSING WAS ALSO OBSERVED IN PREVIOUS FOLLOW-UP (PERFORMED ON (B)(4) 2012) FILE. AGAIN, NOISE EPISODES WERE CORRELATED TO PT ACTIVITY INVOLVING VIBRATIONS. AN EXPLANATION AND RECOMMENDATION ARE REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVATIO | MRM | SORIN CRM | OVATIO VR 6250 | S061207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |